Insmed Incorporated (Nasdaq CM: INSM) today announced that it has been notified by the FDA that it is continuing the clinical hold previously placed on its Phase 3 trial for ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease. As announced on August 1, 2011, the clinical holds placed on ARIKACE in NTM and Cystic Fibrosis (CF) patients with Pseudomonas lung infections were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the Agency by Insmed with ARIKACE. At that time, FDA requested additional information on ARIKACE and data from the rat study. Insmed submitted its complete response to this request before the end of August. Insmed has been informed by FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the Agency has insufficient information to assess the risks of ARIKACE in NTM patients in the planned Phase 3 clinical trial. FDA is requiring that Insmed conduct a Phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for ARIKACE in NTM before it can proceed with a Phase 3 clinical trial. In addition, Insmed will also need to further revise the assessment of the rat carcinogenicity study findings in the investigator brochure.
OXiGENE, Inc. (NASDAQ:OXGN) released a filing today saying that it had terminated its Committed Equity Financing Facility with Kingsbridge, pursuant to which Kingsbridge had committed to purchase, subject to certain conditions, up to $40 million of its common stock. According to their latest 10Q as of June 30, 2011, there remained a total of 253,671 shares available for sale under the CEFF and had purchased just over 30,000. The agreement was due to expire May 2012.
Capstone Therapeutics (Nasdaq:CAPS) announced today its plan to preserve cash during ongoing discussions with potential partners regarding AZX100 in dermal scarring. It will reduce staff from its current 18 full-time employees to a core of four individuals covering required regulatory and financial functions at substantially reduced compensation.